Devices
Four Democrat U.S. senators are urging FDA to initiate a post market study of pulse oximeters and seeking information about the agency’s clearance process for pulse oximeters to ensure they are effective across racially diverse patients and consumers. In a letter to FDA commissioner Robert Califf, Elizabeth Warren
Biologics
FDA has granted Daiichi Sankyo accelerated approval for Enhertu (fam-trastuzumab deruxtecan-nxki) for treating adult patients with unresectable or metastatic non-small cell lung cancer whose tumors have activating human epidermal growth factor receptor 2 HER2 mutations (as detected by an FDA-approved test). The agency also approved Life
Drugs
An Avadel CNS Pharmaceuticals suit filed in July challenges FDA’s authority to compel patent certifications when a section viii statement has been submitted. Attorney Sara Koblitz (Hyman, Phelps & McNamara) writes in her firm’s FDA Law Blog that the case involves Avadel’s Lumryz, a sodium oxybate drug
Drugs
FDA has informed France’s MaaT Pharma that its clinical hold on the company’s IND for a Phase 3 trial of its MaaT013 drug candidate in patients with steroid-resistant acute graft-versus-host disease remains in place. MaaT says FDA acknowledged that it received satisfactory answers from the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Mammography Quality Standards Act Requirements —21 CFR part 900” (OMB Control Number 0910-0309). The collection pertains to requirements in the Mammography Quality Standards Act for a federal certification and inspection program for mammography facilities; standards for
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled: “Environmental Impact Considerations” (OMB Control Number 0910-0322). The agency notes that all applications or petitions requesting FDA action require the submission of an environmental assessment or a claim of categorical exclusion. To view the notice, click
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Medical Device Accessories” (OMB Control Number 0910-0823). The collection supports FDA recommendations in its guidance on “Medical Device Accessories — Describing Accessories and Classification Pathways.” The document explains what devices the agency generally considers an “accessory” and
Devices
FDA says the Becton Dickinson 6/20 recall of intraosseous needle set kits, manual driver kits, and powered drivers is Class 1. An agency notice says the company recalled 2,207 drills and 34,355 needle sets that were distributed between 1/20/20 and 5/5/22. The notice
Drugs
Italy’s Menarini Group, with support from Radius Health, has submitted an NDA to FDA for elacestrant in patients with ER+/HER2- advanced breast cancer. An announcement says the companies requested a priority review. The companies say the submission is based on positive Phase 3 data from the EMERALD study
Devices
An FDA 8/11 safety communication regarding serial use of at-home Covid-19 antigen tests was based on recommendations from a study by the University of Massachusetts Chan Medical School. The university says the study results show that at-home antigen tests are more likely to detect Covid-19
Drugs
The New Jersey federal court hearing the Proton-Pump Inhibitor Products Liability Litigation is considering a challenge to a former FDAer who was to appear as an expert witness. Attorney James Beck (Reed Smith) writes in a Drug & Device Law post that the witness was challenged under a federal
Drugs
FDA has granted full approval to Novartis for its previously accelerated-approved Tabrecta (capmatinib) for treating adult patients with metastatic non-small cell lung cancer whose tumors have a mutation leading to mesenchymal-epithelial transition exon 14 skipping (as detected by an FDA-approved test). Accelerated approval was gained 5/
Devices
FDA has cleared a ClearPoint Neuro 510(k) for its ClearPoint Maestro Brain Model, software for automatic labeling, visualization, volumetric and shape quantification of segmentable brain structures from a set of MRI images. “The current version will enable reproducible analysis of patient data which will provide immediate value for our
Drugs
The Biosimilars Forum says it is concerned that an FDA draft guidance on risk management plans (RMP) to mitigate the potential for drug shortages “is not well tailored to achieving this purpose.” The forum’s 8/4 comment letter says the draft guidance “is not consistent with the law and
Drugs
The Colorado Society of Addiction Medicine, supported by similar societies in eight states, is calling on FDA to update the labeling of sublingual buprenorphine products to treat opioid use disorder. The society petition wants the labeling to indicate that following initiation, the buprenorphine dose should be titrated based on the
Devices
Although the formal deadline has passed for submitting comments on an FDA discussion paper on strengthening cybersecurity practices with servicing of medical devices, Philips is providing additional comments to bolster the feedback it previously submitted. The company’s 8/4 letter gives additional information in response to three questions posed
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Patent Term Restoration; Due Diligence Petitions; Filing, Format, and Content of Petitions—21 CFR Part 60” (OMB Control Number 0910-0233). The petitions address the part of a patent term that may be consumed during FDA’s
FDA Policy/General
Federal Register notice: FDA is making available a publication entitled “Modifications to the List of Recognized Standards, Recognition List Number: 058.” The document is intended to assist manufacturers who elect to declare conformity with consensus standards to meet certain requirements for medical devices. To view the notice, click here.
Drugs
FDA says that to avoid a shortage, it will not object to the temporary distribution of sitagliptin (Merck’s Januvia) with the nitrosamine impurity Nitroso-STG-19 (NTTP) above the acceptable intake limit of 37 ng/day and up to 246.7 ng/day. An agency notice says FDA recently
Drugs
Janssen says an FDA draft guidance on clinical pharmacology considerations for human radiolabeled mass balance studies is well written and provides sponsors with much-needed guidance when conducting mass balance studies. The firm’s comment also has specific suggestions for strengthening the draft. AbbVie says recent microtracer approaches using accelerator
Devices
FDA has given 510(k) clearance for the ReShape Lifesciences Gastro Intestinal Balloon Indicator calibration tube for use in gastric and bariatric surgical procedures. The company says the tubes are available in three sizes and will simplify gastric and bariatric procedures including laparoscopic sleeve gastrectomy, gastric bypass, and gastric banding.
FDA Policy/General
Combatting misinformation is a top priority for FDA and commissioner Robert Califf, and in addressing this the agency has launched a new Web page dedicated to stopping rumors from spreading. The “Rumor Control” page encourages the public to not believe rumors, not pass them along, and get information from trusted